Ignite Creation Date:
2025-12-25 @ 2:36 AM
Ignite Modification Date:
2025-12-26 @ 1:13 AM
Study NCT ID:
NCT00336934
Status:
COMPLETED
Last Update Posted:
2011-08-15
First Post:
2006-06-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pomegranate Extract in Treating Patients With Rising Prostate-Specific Antigen Levels After Surgery or Radiation Therapy for Localized Prostate Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 183}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-08', 'dispFirstSubmitDate': '2011-03-15', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-08-08', 'studyFirstSubmitDate': '2006-06-13', 'dispFirstSubmitQcDate': '2011-05-16', 'studyFirstSubmitQcDate': '2006-06-13', 'dispFirstPostDateStruct': {'date': '2011-05-19', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2011-08-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-06-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective response', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'Response duration', 'timeFrame': '12 months'}, {'measure': 'Effects of pomegranate extract on prostate-specific antigen (PSA) doubling and velocity times', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['adenocarcinoma of the prostate', 'recurrent prostate cancer', 'stage I prostate cancer', 'stage II prostate cancer', 'stage III prostate cancer', 'stage IV prostate cancer'], 'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Pomegranate extract may keep prostate cancer from growing in patients with rising prostate-specific antigen (PSA) levels after surgery or radiation therapy for localized prostate cancer.\n\nPURPOSE: This randomized trial is studying how well pomegranate extract works in treating patients with rising PSA levels after surgery or radiation therapy for localized prostate cancer.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Evaluate the effects of pomegranate extract in patients with and rising prostate-specific antigen (PSA) levels after surgery or radiotherapy for localized prostate cancer.\n* Determine the effect of a daily oral dose of pomegranate extract on the absolute value of PSA and on the change in PSA doubling time in these patients.\n\nSecondary\n\n* Assess toxicities associated with daily oral dosing of pomegranate extract in these patients.\n* Determine the effect of pomegranate extract on positive PSA doubling-time outcome, defined as greater than 150% baseline or a negative post-treatment PSA doubling time (i.e., declining PSA).\n\nOUTLINE: This is a multicenter, double-blind, placebo-controlled, randomized study. Patients are stratified according to participating center. Patients are randomized to 1 of 2 treatment arms.\n\n* Arm I: Patients receive oral pomegranate extract daily.\n* Arm II: Patients receive oral placebo daily. Treatment in both arms continues for up to 1 year in the absence of disease progression.\n\nPROJECTED ACCRUAL: A total of 180 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed adenocarcinoma of the prostate\n* Must have completed prior surgery, cryotherapy, or radiotherapy for the primary tumor\n* Documented rising prostate-specific antigen (PSA)\n\n * Absolute level of PSA \\> 0.2 ng/mL after surgery\n * Absolute level of PSA \\> 1.0 ng/mL after radiation or cryotherapy\n * Absolute level of PSA ≥ 0.4 ng/mL after multiple treatment modalities (e.g., surgery with radiotherapy or radiotherapy with cryotherapy)\n * PSA must be ≥ 100% above best nadir achieved\n * PSA doubling time \\> 3 months or ≤ 24 months\n\n * Patients must have ≥ 3 rising PSA time points above the minimum nadir achieved over ≥ 6 months\n\n * The interval between PSA time points must be \\> 2 weeks\n* PSA ≤ 7.0 ng/mL\n* Patients who underwent radical prostatectomy and never achieved undetectable serum PSA after surgery are not eligible\n* Gleason score ≤ 7\n* No histologically positive lymph nodes\n* No evidence of metastatic disease by physical examination, CT scan, or bone scan\n\nPATIENT CHARACTERISTICS:\n\n* Life expectancy ≥ 6 months\n* ECOG performance status 0 or 1\n* No significant concomitant medical or psychiatric conditions that would limit study compliance\n* No known allergies to pomegranate extract\n* No known diabetes with hemoglobin A\\_1c level \\> 7.0% in the past 3 months\n\n * Diabetic patients entering study who have not had hemoglobin A\\_1c level measured in the past 3 months must have levels measured at study initiation\n* No clinically abnormal laboratory values \\> 2 times the upper limit of normal\n\nPRIOR CONCURRENT THERAPY:\n\n* See Disease Characteristics\n* More than 4 weeks since prior and no concurrent experimental drugs, high-dose steroids, or other cancer treatment\n* No hormonal therapy, with the exception of neoadjuvant androgen-deprivation therapy (ADT), prior to or concurrent with primary therapy\n\n * Patients who received prior neoadjuvant ADT must have serum testosterone ≥ 150 ng/dL\n* No prior or concurrent hormonal therapy for rising PSA after primary therapy for prostate cancer\n* No finasteride or dutasteride at any time point after primary therapy and during study therapy\n* No other concurrent commercial pomegranate products\n* No other concurrent systemic or local therapy for prostate cancer\n* Concurrent dietary/herbal supplements (e.g., saw palmetto or selenium) allowed provided dose has been stable for ≥ 2 months prior to study entry and there are no plans to change or stop the supplements during study therapy'}, 'identificationModule': {'nctId': 'NCT00336934', 'briefTitle': 'Pomegranate Extract in Treating Patients With Rising Prostate-Specific Antigen Levels After Surgery or Radiation Therapy for Localized Prostate Cancer', 'nctIdAliases': ['NCT00413530'], 'organization': {'class': 'INDUSTRY', 'fullName': 'Roll International Corporation'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled Study of The Effects of Pomegranate Extract On Rising Prostate-Specific Antigen Levels In Men Following Primary Therapy', 'orgStudyIdInfo': {'id': 'CDR0000480402'}, 'secondaryIdInfos': [{'id': 'P30CA016042', 'link': 'https://reporter.nih.gov/quickSearch/P30CA016042', 'type': 'NIH'}, {'id': 'ROLL-GUP-0205-1'}, {'id': 'UCLA-0507059-01'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm I', 'description': 'Patients receive oral pomegranate extract daily.', 'interventionNames': ['Dietary Supplement: pomegranate juice']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Arm II', 'description': 'Patients receive oral placebo daily.', 'interventionNames': ['Other: placebo']}], 'interventions': [{'name': 'pomegranate juice', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Given orally daily.', 'armGroupLabels': ['Arm I']}, {'name': 'placebo', 'type': 'OTHER', 'description': 'Given orally daily.', 'armGroupLabels': ['Arm II']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Allan Pantuck, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jonsson Comprehensive Cancer Center'}, {'name': 'Arie Belldegrun, MD, FACS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jonsson Comprehensive Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Roll International Corporation', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'oldNameTitle': 'MaryBethAudickas', 'oldOrganization': 'Radiant Research - Chicago'}}}}